Headgear for mask assembly

ABSTRACT

A mask system for use between a patient and a structure to deliver a breathable gas to the patient includes a mask assembly including a frame, a cushion provided to the frame, and optionally an elbow provided to the frame. Headgear is removably attached to the mask assembly to maintain the mask assembly in a desired position on a patient&#39;s face. The headgear includes a top strap, crown straps which cooperate to form a round shape adapted to accommodate a crown of the patient&#39;s head, and bottom straps.

CROSS-REFERENCE TO APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/697,365, filed Jul. 8, 2005, which is incorporated herein byreference in its entirety.

Also, PCT Application No. PCT/AU2004/001813, filed Dec. 22, 2004, isincorporated herein by reference, in its entirety.

FIELD OF THE INVENTION

The invention relates to headgear for use in holding amask assembly inposition on a patient's face, the mask assembly being used forNon-invasive Positive Pressure Ventilation (NPPV) and for continuouspositive airway pressure (CPAP) therapy of sleep disordered breathing(SDB) conditions such as obstructive sleep apnea (OSA).

BACKGROUND OF THE INVENTION

Mask assemblies used for treatment of SDB such as OSA are typically heldon a patient's head by headgear. Headgear typically includes one or moreheadgear straps that are adapted to engage with the mask assembly andhold the mask assembly in position on the patient's face. In addition,headgear should be comfortable so that a patient can wear the maskassembly at night while they sleep. There is a continuous need in theart for headgear that is comfortable, fits a wide range of patients, iseasily manufactured, and is inexpensive.

SUMMARY OF THE INVENTION

One aspect of the invention relates to headgear that provides comfortand ease of adjustability to a wide range of patients.

Another aspect of the invention relates to headgear that provides acompact configuration to reduce material costs.

Another aspect of the invention relates to a mask system for use betweena patient and a structure to deliver a breathable gas to the patient.The mask system includes a mask assembly including a frame and a cushionprovided to the frame. Headgear is removably attached to the maskassembly to maintain the mask assembly in a desired position on apatient's face. The headgear includes a back headgear section providinga top strap, a pair of side straps attached to the back headgearsection, and an elastic strap attached between the back headgear sectionand the pair of side straps.

Another aspect of the invention relates to headgear for use with a maskassembly. The headgear includes a back headgear section providing a topstrap, a pair of side straps attached to the back headgear section, andan elastic strap attached between the back headgear section and the pairof side straps.

Another aspect of the invention relates to a method for forming headgearfor a mask assembly. The method includes forming a back headgear sectionincluding a top strap adapted for connection to a top portion of themask assembly, attaching a pair of side straps to the back headgearsection adapted for connection to side portions of the mask assembly,and attaching an elastic strap between the back headgear section and thepair of side straps.

Another aspect of the invention relates to headgear for use with a maskassembly. The headgear includes a top strap, a bottom strap sectionincluding bottom straps and a connector, and a crown strap sectionincluding crown straps and a connector attached to the connector of thebottom strap section. Ends of the crown straps are attached to oneanother and to an end of the top strap. The crown straps cooperate toform a round shape or halo that is adapted to accommodate a crown of apatient's head.

Another aspect of the invention relates to headgear for use with a maskassembly. The headgear includes a top strap, a first strap sectionincluding a first crown strap, a first bottom strap, and a firstconnector, and a second strap section including a second crown strap, asecond bottom strap, and a second connector. The second connector isattached to the first connector and ends of the first and second crownstraps are attached to one another and to an end of the top strap. Thefirst and second crown straps cooperate to form a round shape or halothat is adapted to accommodate a crown of a patient's head.

Another aspect of the invention relates to headgear for use with a maskassembly. The headgear includes a top strap, a first cross strapincluding a first crown strap portion, a first bottom strap portion, anda first connector portion, and a second cross strap including a secondcrown strap portion, a second bottom strap portion, and a secondconnector portion. The second connector portion is attached to the firstconnector portion so that the first and second cross straps extendtransverse to one another. Ends of the first and second crown strapportions are attached to one another and to an end of the top strap. Thefirst and second crown strap portions cooperate to form a round shape orhalo that is adapted to accommodate a crown of a patient's head.

Another aspect of the invention relates to a method for forming headgearfor a mask assembly. The method includes forming a bottom strap sectionincluding bottom straps and a connector, a crown strap section includingcrown straps and a connector, and a top strap; attaching the connectorof the bottom strap section to the connector of the crown strap section;attaching ends of the crown straps to one another so that the crownstraps cooperate to form a round shape or halo that is adapted toaccommodate a crown of a patient's head; and attaching an end of the topstrap to the ends of the crown straps.

Another aspect of the invention relates to a method for forming headgearfor a mask assembly. The method includes forming a first strap sectionincluding a first crown strap, a first bottom strap, and a firstconnector, a second strap section including a second crown strap, asecond bottom strap, and a second connector, and a top strap; attachingthe first connector to the second connector; attaching ends of the firstand second crown straps to one another so that the first and secondcrown straps cooperate to form a round shape or halo that is adapted toaccommodate a crown of a patient's head; and attaching an end of the topstrap to the ends of the first and second crown straps.

Another aspect of the invention relates to a method for forming headgearfor a mask assembly. The method includes forming a first cross strapincluding a first crown strap portion, a first bottom strap portion, anda first connector portion, a second cross strap including a second crownstrap portion, a second bottom strap portion, and a second connectorportion, and a top strap; attaching the first connector portion to thesecond connector portion so that the first and second cross strapsextend transverse to one another; attaching ends of the first and secondcrown strap portions to one another so that the first and second crownstrap portions cooperate to form a round shape or halo that is adaptedto accommodate a crown of a patient's head; and attaching an end of thetop strap to the ends of the first and second crown strap portions.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a side view of headgear constructed according to an embodimentof the present invention, the headgear in position on a patient's headto hold a mask assembly in position on a patient's face;

FIG. 2 is a perspective view of the headgear shown in FIG. 1 removedfrom the mask assembly and the patient's head;

FIG. 3 is a top view of the headgear shown in FIG. 2;

FIG. 4A is a side view of the headgear shown in FIG. 2;

FIG. 4B is an enlarged view of a portion of the headgear shown in FIG.4A;

FIG. 5 is a plan view of a back headgear section of the headgear shownin FIG. 2;

FIG. 6 is a plan view of the back headgear section shown in FIG. 5 andshowing dimensions of an embodiment;

FIG. 7 is a rear view of the headgear shown in FIG. 1 in position on apatient's head;

FIG. 8 is a rear perspective view of the headgear shown in FIG. 1 inposition on a patient's head;

FIG. 9 is an exploded view of headgear according to another embodimentof the present invention;

FIG. 10 illustrates a nesting arrangement for manufacturing the headgearshown in FIG. 9;

FIG. 11 is an assembled view of the headgear shown in FIG. 9;

FIG. 12 is a side view of the headgear shown in FIG. 9 in position on apatient's head to hold a mask assembly in position on a patient's face;

FIG. 13 is a rear view of the headgear shown in FIG. 9 in position on apatient's head to hold a mask assembly in position on a patient's face;

FIG. 14 is a plan view of a bottom strap section of the headgear shownin FIG. 9 and showing dimensions of an embodiment;

FIG. 15 is a plan view of a crown strap section of the headgear shown inFIG. 9 and showing dimensions of an embodiment;

FIGS. 16-17 are plan and side views of a top strap of the headgear shownin FIG. 9 and showing dimensions of an embodiment;

FIG. 18 is an exploded view of headgear according to another embodimentof the present invention;

FIG. 19 illustrates a nesting arrangement for manufacturing the headgearshown in FIG. 18;

FIG. 20 is an assembled view of the headgear shown in FIG. 18;

FIG. 21 is a partial assembled view of headgear according to yet anotherembodiment of the present invention, and showing dimensions of anembodiment;

FIG. 22 is a plan view of a top strap of the headgear shown in FIG. 21and showing dimensions of an embodiment;

FIG. 23 is an assembled view of the headgear shown in FIGS. 21 and 22;

FIG. 24 is a side view of the headgear shown in FIG. 23 in position on apatient's head to hold a mask assembly in position on a patient's face;and

FIG. 25 is a rear view of the headgear shown in FIG. 23 in position on apatient's head to hold a mask assembly in position on a patient's face.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The figures illustrate headgear 10, 210, 310, 410 constructed accordingto embodiments of the present invention. In the illustrated embodiments,the headgear 10, 210, 310, 410 are adapted to be removably attached to amask assembly 50 of the type described below to hold and maintain themask assembly 50 in a desired position on a patient's face.

1. Mask Assembly

As shown in FIGS. 1, 12, and 24 for example, the mask assembly 50includes a frame 52 in the form of a shell, and a cushion 54 that isprovided, e.g., attached, to the frame 52. A swivel elbow 56 isrotatably coupled or provided to the frame 52. The swivel elbow 56 isstructured to be connected to an air delivery tube that deliversbreathable gas to the patient, as is known in the art.

Side portions of the frame 52 include lateral outriggers 58 whichsupport connector clip receptacles designed to receive connector clips60 associated with the headgear 10, 210, 310, 410. A top portion of theframe 52 includes a centrally located upper extension 62 includingvarious structure to interlock with a headgear strap of the headgear 10,210, 310, 410.

Further details and embodiments of the mask assembly 50 are disclosed inPCT Application No. PCT/AU2004/001813, filed Dec. 22, 2004, the entiretyincorporated herein by reference. While the headgear 10, 210, 310, 410is described as being used with a mask assembly 50 of the type describedabove, it may be adapted for use with other suitable mask assemblies.That is, the mask assembly 50 is merely exemplary, and aspects of theheadgear 10, 210, 310, 410 may be adapted for use with any suitable maskassembly, e.g., a full-face (oro-nasal) mask, a mouth (oro) mask, or anasal mask.

2. First Illustrated Headgear Embodiment

FIGS. 1-8 illustrate headgear 10 according to an embodiment of thepresent invention. As shown in FIGS. 2, 3, 4A, and 4B, the headgear 10includes an assembly of four parts. Specifically, the headgear 10includes a back headgear section 20, a pair of side straps 30, 32, andan elastic strap 40. The back headgear section 20 includes a top strap22, bottom straps 24, 26 extending from the top strap 22, and aconnector strap 28 extending between intermediate portions of the bottomstraps 24, 26.

In an embodiment, the back headgear section 20 may be manufactured bystarting with a substantially flat piece of appropriate headgearmaterial, such as polyester loop material, Breathoprene®, leather,cloth, plastic, etc., and then cutting, scoring or weakening theheadgear material along predetermined cut lines to form the desiredshape of the back headgear section 20 as shown in FIG. 5. The connectorstrap 28 may be created with a plurality of slits 70 that allow thestrap 28 to expand in use to form open spaces as discussed below. Theside straps 30, 32 may also be cut from a substantially flat piece ofappropriate headgear material to form the desired shape of the sidestraps 30, 32. The elastic strap 40 may be cut or otherwise manufacturedfrom a substantially flat piece of elastic material to form the desiredshape of the elastic strap 40.

FIG. 5 illustrates the back headgear section 20, and FIG. 6 illustratesexemplary dimensions of an embodiment of the back headgear section 20.In an embodiment of the back headgear section 20 (as shown in FIG. 6),D₁ is 494 mm, D₂ is 200 mm, D₃ is 16 mm, D₄ is 19 mm, D₅ is 76 mm, D₆ is19 mm, D₇ is 19 mm, D₈ is 87.5 mm, D₉ is 23.9 mm, D₁₀ is 38.4 mm, D₁₁ is11.5 mm, D₁₂ is 73.5 mm, D_is R6 mm, D₁₄ is R8 mm, D₁₅ is R6 mm, D₁₆ is40.8 mm, D₁₇ is R38 mm, D₁₈ is R19 mm, and D₁₉ is R37 mm. The thicknessT of the material, e.g., laminated material, may be 2.3±0.3 mm. In anembodiment, the material for the back headgear section 20 may be cut sothat minimum elasticity is along the direction of the top strap 22.

Also, in an embodiment, the side straps 30, 32 may have a width similarto the width of the top strap 22 of the back headgear section 20, e.g.,about 19 mm. Further, in an embodiment, the elastic strap 40 may beconstructed of VELSTRECH® loop elastic and may have a length of about130±5 mm. Although specific dimensions and ranges of the back headgearsection 20, the side straps 30, 32, and the elastic strap 40 areindicated, it is to be understood that these dimensions and ranges aremerely exemplary and other dimensions and ranges are possible dependingon application. For example, the exemplary dimensions may vary by 10-20%or more or less depending on application.

The back headgear section 20, the side straps 30, 32, and the elasticstrap 40 are attached to one another to form the headgear 10. As shownin FIGS. 2, 3, 4A, and 4B, ends of the elastic strap 40 are attached torespective ends of the bottom straps 24, 26 such that the elastic strap40 extends between and transversely to the bottom straps 24, 26. Also,each side strap 30, 32 is attached to a respective end of the elasticstrap 40 and a respective bottom strap 24, 26 such that each side strap30, 32 extends transversely to the bottom straps 24, 26.

As best shown in FIG. 4B, the attachment area forms three layers ofmaterial, i.e., respective bottom strap 24, 26, elastic strap 40, andrespective side strap 30, 32, and the three layers are attached to oneanother by stitching, e.g., a square-shaped stitch. However, the strapsmay be coupled to one another in any other suitable manner, e.g., glued,welded, or otherwise formed.

Further, the elastic strap 40 has a length that is greater than a gapbetween the bottom straps 24, 26, as best shown in FIGS. 2 and 3. Whenthe headgear 10 is in its flat configuration removed from the patient'shead, the elastic strap 40 creates a fold due to its greater length.When the headgear 10 is on the patient's head, the elastic strap 40 willresiliently expand and conform to the patient's head as discussed below.

FIGS. 1, 7, and 8 illustrate the assembled headgear 10 attached to themask assembly 50 and positioned on the patient's head. As illustrated,the headgear 10 is attached to the mask assembly 50 by attaching the topstrap 22 to the centrally located upper extension 62 of the frame 52,and by attaching the side straps 30, 32 to respective connector clips 60that are received in clip receptacles of the frame 52. Each of the upperextension 62 and connector clips 60 includes a crossbar that enables theend portion of the respective top strap 22 and side straps 30, 32 to bewrapped around in a known manner. However, the top strap 22 and sidestraps 30, 32 may be attached to the mask assembly 50 in other suitablemanners.

In use, the connector strap 28 expands via the slits 70 and the elasticstrap 40 expands via its elasticity to form a open spaces 80 when theheadgear 10 is placed on the patient's head. As illustrated, theheadgear 10 conforms to the shape of the patient's head and theconnector strap 28 and upper portions of the bottom straps 24, 26 cupthe occiput of the patient' head.

Also, the headgear 10 includes a fold lines 90 in at least the connectorstrap 28 which are created when the headgear 10 is positioned on thepatient's head. Both the fold lines 90 and the elasticity of the elasticstrap 40 helps to conform the headgear 10 to the patient's head.

2.1 Advantages of First Illustrated Headgear Embodiment

The configuration of headgear 10 provides several advantages. Forexample, the headgear configuration allows both the back headgearsection 20 and the headgear side straps 30, 32 to be cut from arelatively small piece of flat headgear material. That is, the headgearconfiguration is relatively compact and is designed to expand alongslits upon use by the patient. This arrangement reduces material costs.

This configuration also uses a relatively short elastic strap 40 whichprovides comfort and ease of adjustability to a wide range of headshapes, while not requiring a large expanse of relatively expensiveelastic material. This arrangement also reduces material costs.

3. Alternative Headgear Embodiments

FIGS. 9-25 illustrate headgear 210, 310, 410 according to alternativeembodiments of the present invention. In each embodiment, the headgear210, 310, 410 includes an assembly of three parts and forms a round orhalo shaped crown strap that accommodates or captures the crown of thepatient's head.

3.1 First Alternative Headgear Embodiment

FIGS. 9-17 illustrate headgear 210 according to another embodiment ofthe present invention. As best shown in FIG. 9, the headgear 210includes an assembly of three parts. Specifically, the headgear 210includes a bottom strap section 220, a crown strap section 230, and atop strap 240. The bottom strap section 220 includes bottom straps 222,224 and a connector 226 between the bottom straps 222, 224. The crownstrap section 230 includes crown straps 232, 234 and a connector 236between the crown straps 232, 234. As illustrated, the crown straps 232,234 are shorter than the bottom straps 222, 224, e.g., by a distance d.

In an embodiment, the bottom strap section 220, the crown strap section230, and the top strap 240 may be manufactured by starting with asubstantially flat or 2-dimensional piece of appropriate headgearmaterial, and then cutting, scoring or weakening the headgear materialalong predetermined cut lines (e.g., knife cut) to form the desiredshape of the bottom strap section 220, the crown strap section 230, andthe top strap 240. In an embodiment, multiple bottom and crown strapsections 220, 230 may be cut from the same piece of material. Forexample, FIG. 10 illustrates a nesting arrangement for forming multiplebottom and crown strap sections 220, 230 from the same piece ofmaterial.

The two-dimensional bottom strap section 220, crown strap section 230,and top strap 240 are attached to one another, e.g., stitched, welded,glued or otherwise formed, to form a three-dimensional headgear 210.Thus, the headgear 210 achieves a three-dimensional form fromtwo-dimensional cut-out geometries. The three-dimensional form of theheadgear 210 better conforms to the rounded shape of the patient' head.As shown in FIG. 11, the bottom and crown strap sections 220, 230 areattached by attaching ends of respective connectors 226, 236 to oneanother, e.g., along a generally horizontal seam line. Also, ends of thecrown straps 232, 234 are attached to one another and attached to an endof the top strap 240. The crown straps 232, 234 cooperate to form around-shape or halo that accommodates or captures the crown of thepatient's head.

FIGS. 12 and 13 illustrate the assembled headgear 210 attached to themask assembly 50 and positioned on the patient's head. As illustrated,the headgear 210 is attached to the mask assembly 50 at three points,e.g., by attaching the top strap 240 to the centrally located upperextension 62 of the frame 52 and by attaching the bottom straps 222, 224to respective connector clips 60 that are received in clip receptaclesof the frame 52. Each of the upper extension 62 and connector clips 60includes a crossbar that enables the end portion of the respective topstrap 240 and bottom straps 222, 224 to be wrapped around in a knownmanner. However, the top strap 240 and bottom straps 222, 224 may beattached to the mask assembly 50 in other suitable manners.

As illustrated, the headgear 210 conforms to shape of the patient's headand the crown straps 232, 234 form a halo that captures the crown orocciput of the patient's head. The crown strap arrangement providesstability for the headgear 210.

FIGS. 14-17 illustrate dimensions of an embodiment of the bottom strapsection 220, the crown strap section 230, and the top strap 240. In anembodiment of the bottom strap section 220 (as shown in FIG. 14), BD₁ is22.36 mm, BD₂ is 215.13 mm, BD₃ is 228.13 mm, BD₄ is 148.0°, BD₅ isR175.00 mm, BD₆ is R15.00 mm, BD₇ is 80.00 mm, BD₈ is 10.87 mm, BD₉ is27.69 mm, BD₁₀ is 16.00°, BD₁₁ is 77.30 mm, BD₁₂ is 10.00 mm, and BD_is20.00 mm. In an embodiment of the crown strap section 230 (as shown inFIG. 15), CD₁ is 22.36 mm, CD₂ is 195.13 mm, CD₃ is 208.13 mm, CD₄ is148.0°, CD₅ is R175.00 mm, CD₆ is R15.00 mm, CD₇ is 80.00 mm, CD₈ is10.87 mm, CD₉ is 27.69 mm, CD₁₀ is 16.00°, CD₁₁ is 71.79 mm, CD₁₂ is10.00 mm, and CD_is 20.00 mm. In an embodiment of the top strap 240 (asshown in FIGS. 16 and 17), TD₁ is 240.00 mm, TD₂ is 20.00 mm, and TD₃ is2.00 mm. Although specific dimensions are provided, it is to beunderstood that these dimensions are Merely exemplary and otherdimensions are possible depending on application. For example, theexemplary dimensions may vary by 10-20% or more or less depending onapplication.

3.2 Second Alternative Headgear Embodiment

FIGS. 18-20 illustrate headgear 310 according to another embodiment ofthe present invention. The headgear 310 in its assembled condition issubstantially similar to the headgear 210 described above. In contrast,the assembled components of the headgear 310 are different.

As best shown in FIG. 18, the headgear 310 includes an assembly of threeparts. Specifically, the headgear 310 includes a first strap section320, a second strap section 330, and a top strap 340. The first strapsection 320 includes a crown strap 322, a bottom strap 324, and aconnector 326 between the straps 322, 324. The second strap section 330includes a crown strap 332, a bottom strap 334, and a connector 336between the straps 332, 334. As illustrated, the crown straps 322, 332are shorter than the bottom straps 324, 334, e.g., by a distance d.

In an embodiment, the first strap section 320, the second strap section330, and the top strap 340 may be manufactured by starting with asubstantially flat or 2-dimensional piece of appropriate headgearmaterial, and then cutting, scoring or weakening the headgear materialalong predetermined cut lines (e.g., knife cut) to form the desiredshape of the first strap section 320, the second strap section 330, andthe top strap 340. In an embodiment, multiple first and second strapsections 320, 330 may be cut from the same piece of material. Forexample, FIG. 19 illustrates a nesting arrangement for forming multiplefirst and second strap sections 320, 330 from the same piece ofmaterial. As illustrated, the first and second strap sections 320, 330are mirror images of one another, and include the same structure anddimensions.

The two-dimensional first strap section 320, second strap section 330,and top strap 340 are attached to one another, e.g., stitched, welded,glued or otherwise formed, to form a three-dimensional headgear 310.Thus, the headgear 310 achieves a three-dimensional form fromtwo-dimensional cut-out geometries. The three-dimensional form of theheadgear 310 better conforms to the rounded shape of the patient' head.As shown in FIG. 20, the first and second strap sections 320, 330 areattached by attaching ends of respective connectors 326, 336 to oneanother, e.g., along a generally vertical seam line. Also, ends of thecrown straps 322, 332 are attached to one another and attached to an endof the top strap 340. Similar to the headgear 210, the crown straps 322,332 cooperate to form a round-shape or halo that accommodates orcaptures the crown of the patient's head.

The assembled headgear 310 may be attached to the mask assembly 50 andpositioned on the patient's head in a manner as described above withrespect to headgear 210, e.g., attaching the top strap 340 to thecentrally located upper extension 62 and attaching the bottom straps324, 334 to respective connector clips 60.

3.3 Third Alternative Headgear Embodiment

FIGS. 21-25 illustrate headgear 410 according to yet another embodimentof the present invention. As best shown in FIGS. 21 and 22, the headgear410 includes an assembly of three parts. Specifically, the headgear 410includes a first cross strap 420, a second cross strap 430, and a topstrap 440. As illustrated, the first and second cross straps 420, 430include the same structure and dimensions. The first cross strap 420includes a crown strap portion 422, a bottom strap portion 424, and aconnector portion 426 between the strap portions 422, 424. The secondcross strap 430 includes a crown strap portion 432, a bottom strapportion 434, and a connector portion 436 between the strap portions 432,434. As illustrated, the crown strap portions 422, 432 are shorter thanthe bottom strap portions 424, 434.

In an embodiment, the first cross strap 420, the second cross strap 430,and the top strap 440 may be manufactured by starting with asubstantially flat or 2-dimensional piece of appropriate headgearmaterial, and then cutting; scoring or weakening the headgear materialalong predetermined cut lines to form the desired shape of the firstcross strap 420, the second cross strap 430, and the top strap 440.

The two-dimensional first cross strap 420, second cross strap 430, andtop strap 440 are attached to one another, e.g., stitched, welded, gluedor otherwise formed, to form a three-dimensional headgear 410. Thus, theheadgear 410 achieves a three-dimensional form from two-dimensionalcut-out geometries. The three-dimensional form of the headgear 410better conforms to the rounded shape of the patient' head. As shown inFIG. 23, the first and second cross straps 420, 430 are attached byattaching respective connector portions 426, 436 to one another so thatthe first and second cross straps 420, 430 extend transverse to oneanother. The connector portion 426 may pass under or over the connectorportion 436 (e.g., FIGS. 21 and 23 show the connector portion 426passing under the connector portion 436). Also, ends of the crown strapportions 422, 432 are attached to one another and attached to an end ofthe top strap 440 (e.g., attach A to A to A of the crown strap portions422, 432 and top strap 440 as shown in FIGS. 21 and 22). Similar to theheadgear 210 and 310, the crown strap portions 422, 432 cooperate toform a round-shape or halo that accommodates or captures the crown ofthe patient's head.

FIGS. 24 and 25 illustrate the assembled headgear 410 attached to themask assembly 50 and positioned on the patient's head. As illustrated,the headgear 410 is attached to the mask assembly 50 at three points,e.g., by attaching the top strap 440 to the centrally located upperextension 62 of the frame 52 and by attaching the bottom strap portions424, 434 to respective connector clips 60 that are received in clipreceptacles of the frame 52.

As illustrated, the headgear 410 conforms to shape of the patient's headand the crown strap portions 422, 432 form a halo that captures thecrown or occiput of the patient's head. The crown strap arrangementprovides stability for the headgear 410.

FIGS. 21 and 22 also illustrate dimensions of an embodiment of the firstand second cross straps 420, 430 and the top strap 440. In an embodimentof the cross straps 420, 430 (as shown in FIG. 21), CS₁ is 256 mm, CS₂is 570 mm, CS₃ is 252 mm, CS₄ is 293.6 mm, CS₅ is 297.6 mm, CS₆ is101.3°, CS₇ is 78.7°, and CS₈ is 20 mm. In an embodiment of the topstrap 440 (as shown in FIG. 22), TS₁ is 240 mm and TS₂ is 20 mm.Although specific dimensions are provided, it is to be understood thatthese dimensions are merely exemplary and other dimensions are possibledepending on application. For example, the exemplary dimensions may varyby 10-20% or more or less depending on application.

3.4 Advantages of Alternative Headgear Embodiments

The configuration of headgear 210, 310, 410 provide several advantages.For example, the force vector generated from the top strap 240, 340, 440acts to pull together the Crown straps 232, 234, 322, 332, 422, 432 thatdefine the halo. This arrangement cups the patient's head better andprevents the crown straps from tending to slide downwards over thepatient's head. When viewed from the side (e.g., see FIGS. 12 and 24),the crown straps lie on the top and back of the patient's head, whichprovides a vertical and horizontal reaction force to headgear straptension.

Various head shapes (e.g., ball and egg/pointed) are accommodated for asthe crown of the patient's head partially extends through the holedefined by the halo-shaped crown straps. In an embodiment, thehalo-shaped crown straps immediately capture the crown of the patient'shead when first fitted to the patient. This arrangement minimizes thetime required by busy nurses to fit the mask to the patient.

In an embodiment, one headgear design and size may be provided forsmall, medium, and large sized masks, e.g., full-face masks such as maskassembly 50.

The circumferential length of the crown straps may be sized so that itfits the smallest head (e.g., 5^(th) percentile) in the total adult maleand female population without the head being able to pass through thehalo-shaped crown straps. Also, the circumferential length of the crownstraps may take into account elasticity and creep in the headgearmaterial.

In an embodiment, the elasticity and creep properties of the headgearmaterial of the headgear 210, 310, 410 may be characterised to suit bothvented and non-vented disposable full-face masks. Therefore, a commonheadgear design may be used for both vented and non-vented masks.

Due to higher air pressures (e.g., greater than 30 cmH₂O), non-ventedmasks produce more mask bounce onto the patient's face due to thepressure swings during the inhalation and exhalation cycle. In knownembodiments, vented mask headgear have been fabricated from an elasticmaterial (e.g., AccuMED Breath-O-Prene) and non-vented mask headgearhave had a non-extensible strap sewn into the headgear to eliminateelasticity and mask bounce. The headgear material according toembodiments of headgear 210, 310, 410 may have minimal elasticity,thereby making the headgear suitable for both the vented and non-ventedmasks, e.g., hospital disposable full-face masks. Examples of headgearmaterial for headgear 210, 310, 410 may include polyester, nylon, andfoam.

In an embodiment, the elasticity of the headgear material of headgear210, 310, 410 may be selected such that it provides up to about 65 mm ofdisplacement for forces up to about 0.02 kN. In one acceptable range,the elasticity of the headgear material of headgear 210, 310, 410 may beselected such that it provides up to about 20 mm of displacement forforces up to about 0.02 kN. In a preferred range, the elasticity of theheadgear material of headgear 210, 310, 410 may be selected such that itprovides up to about 14 mm of displacement for forces up to about 0.02kN. In another preferred range, the elasticity of the headgear materialof headgear 210, 310, 410 may be selected such that it provides betweenabout 4 mm and about 14 mm of displacement for forces up to about 0.02kN.

Other advantages of the headgear configuration include a reduction inmaterial waste to increase yield (e.g., nesting arrangement duringmanufacturing), and the consideration of a range of low cost fabricalternatives. The headgear lifespan may improve due to headgear materialthat has less creep and adequate strap lengths to cover anthropometricranges. Also, the headgear has improved structural form when removedfrom packaging, a simplistic design to minimize confusion, and headgearmaterial that has an overall softer look with a higher quality finish.In addition, the structural form of the headgear makes the headgearintuitive to fit onto the patient. The “halo” feature and paddedneck-piece are cognitive devices, and the “halo” feature immediatelycaptures the crown of the patient's head, which centers the headgear.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, bariatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

1-26. (canceled)
 27. Headgear for use with a mask assembly, comprising:a top strap; a bottom strap section including bottom straps and aconnector; and a crown strap section including crown straps and aconnector attached to the connector of the bottom strap section, andends of the crown straps attached to one another and to an end of thetop strap, wherein the crown straps cooperate to form a round shape orhalo that is adapted to accommodate a crown of a patient's head.
 28. Theheadgear according to claim 27, wherein the crown straps are shorterthan the bottom straps.
 29. The headgear according to claim 27, whereinthe top strap, bottom strap section, and crown strap section areconstructed from a substantially flat or 2-dimensional piece ofmaterial, and attached to one another to achieve a 3-dimensional form.30. The headgear according to claim 27, wherein the top strap, bottomstrap section, and crown strap section are constructed from headgearmaterial that provides up to about 14 mm of displacement for forces upto about 0.02 kN.
 31. Headgear for use with a mask assembly, comprising:a top strap; a first strap section including a first crown strap, afirst bottom strap, and a first connector; and a second strap sectionincluding a second crown strap, a second bottom strap, and a secondconnector, the second connector being attached to the first connectorand ends of the first and second crown straps being attached to oneanother and to an end of the top strap, wherein the first and secondcrown straps cooperate to form a round shape or halo that is adapted toaccommodate a crown of a patient's head.
 32. The headgear according toclaim 31, wherein the first and second crown straps are shorter than thefirst and second bottom straps.
 33. The headgear according to claim 31,wherein the top strap, first strap section, and second strap section areconstructed from a substantially flat or 2-dimensional piece ofmaterial, and attached to one another to achieve a 3-dimensional form.34. The headgear according to claim 31, wherein the top strap, firststrap section, and second strap section are constructed from headgearmaterial that provides up to about 14 mm of displacement for forces upto about 0.02 kN.
 35. Headgear for use with a mask assembly, comprising:a top strap; a first cross strap including a first crown strap portion,a first bottom strap portion, and a first connector portion; and asecond cross strap including a second crown strap portion, a secondbottom strap portion, and a second connector portion, the secondconnector portion being attached to the first connector portion so thatthe first and second cross straps extend transverse to one another andends of the first and second crown strap portions being attached to oneanother and to an end of the top strap, wherein the first and secondcrown strap portions cooperate to form a round shape or. halo that isadapted to accommodate a crown of a patient's head.
 36. The headgearaccording to claim 35, wherein the first and second crown strap portionsare shorter than the first and second bottom strap portions.
 37. Theheadgear according to claim 35, wherein the top strap, first crossstrap, and second cross strap are constructed from a substantially flator 2-dimensional piece of material, and attached to one another toachieve a 3-dimensional form.
 38. The headgear according to claim 35,wherein the top strap, first cross strap, and second cross strap areconstructed from headgear material that provides up to about 14 mm ofdisplacement for forces up to about 0.02 kN.
 39. A mask system for usebetween a patient and a structure to deliver a breathable gas to thepatient, the mask system comprising: a mask assembly including a frameand a cushion provided to the frame; and headgear according to claim 27.40. A method for forming headgear for a mask assembly, the methodcomprising: forming a bottom strap section including bottom straps and aconnector, a crown strap section including crown straps and a connector,and a top strap; attaching the connector of the bottom strap section tothe connector of the crown strap section; attaching ends of the crownstraps to one another so that the crown straps cooperate to form a roundshape or halo that is adapted to accommodate a crown of a patient'shead; and attaching an end of the top strap to the ends of the crownstraps.
 41. The method according to claim 40, wherein forming a bottomstrap section and/or forming a crown strap section includes formingmultiple sections from the same piece of material in a nestingarrangement.
 42. A method for forming headgear for a mask assembly, themethod comprising: forming a first strap section including a first crownstrap, a first bottom strap, and a first connector, a second strapsection including a second crown strap, a second bottom strap, and asecond connector, and a top strap; attaching the first connector to thesecond connector; attaching ends of the first and second crown straps toone another so that the first and second crown straps cooperate to forma round shape or halo that is adapted to accommodate a crown of apatient's head; and attaching an end of the top strap to the ends of thefirst and second, crown straps.
 43. The method according to claim 42,wherein forming a first strap section and/or forming a second strapsection includes forming multiple sections from the same piece ofmaterial in a nesting arrangement.
 44. A method for forming headgear fora mask assembly, the method comprising: forming a first cross strapincluding a first crown strap portion, a first bottom strap portion, anda first connector portion, a second cross strap including a second crownstrap portion, a second bottom strap portion, and a second connectorportion, and a top strap; attaching the first connector portion to thesecond connector portion so that the first and second cross strapsextend transverse to one another; attaching ends of the first and secondcrown strap portions to one another so that the first and second crownstrap portions cooperate to form a round shape or halo that is adaptedto accommodate a crown of a patient's head; and attaching an end of thetop strap to the ends of the first and second crown strap portions. 45.The method according to claim 44, wherein the first and second crownstrap portions are shorter than the first and second bottom strapportions.
 46. The method according to claim 44, wherein the top strap,first cross strap, and second cross strap are constructed from asubstantially flat or 2-dimensional piece of material, and attached toone another to achieve a 3-dimensional form.
 47. The method according toclaim 44, wherein the top strap, first cross strap, and second crossstrap are constructed from headgear material that provides up to about14 mm of displacement for forces up to about 0.02 kN.